I-Corps: An Implantable, Bioresorbable Medical Device to Regenerate A Damaged Esophagus

Tulane University, New Orleans LA

Investigators

Abstract

A severely impaired esophagus (organ providing food to the stomach) requires a last resort surgical procedure called an esophagectomy. This surgery involves cutting out a damaged portion of an esophagus (i.e. a tumor) and then replacing the missing esophageal tissue by pulling up the stomach (i.e. gastric pull-up). This causes a very low quality of life for the patient because the stomach is not a suitable replacement for an esophagus, often requiring patients to rely on feeding tubes for the length of their survival. Furthermore, post-operative complication rates are as high as 80% and the 5-year survival rate is less than 20%. In order to avoid a gastric pull-up surgery and spare the stomach, this I-Corps team aims to implant the proposed absorbable medical device into the excised damaged portion of the esophagus, promoting functional esophageal tissue regeneration within the body. Ultimately, this will improve the quality of life and survival of the patients, while substantially decreasing reimbursable medical costs than compared to a standard esophagectomy procedure. The proposed device will treat patients that suffer from advanced Barrett's Esophagus (chronic regurgitation of stomach acid), esophageal cancer, esophageal birth defects, and injury to the esophagus due to caustic ingestion of poisons. This I-Corps team is developing an implantable, bioresorbable medical device to functionally regenerate a damaged esophagus. Overall the device is anti-inflammatory, biocompatible/non-immunogenic, bioresorbable, easily packaged (a minimum one year shelf life), and readily available "off the shelf" to be used in the clinic by the thoracic surgeon. This team plans to conduct customer interviews with thoracic surgeons, anesthesiologists, and gastroenterologists during the I-Corps program. The team would like to initiate a large pig study, yielding proof-of-concept that the proposed device is capable of regenerating a damaged esophagus in humans. A more pragmatic proof-of-concept study at the end of the I-Corps project is demonstrating biocompatibility, biodegradability, and immune tolerance of the proposed device in mouse models. This would provide the team significant information to successfully apply for other grants such as the NSF SBIR Phase I.